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Fracture HumerusPhase 2TXANCT05802238

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

A Phase 2 study testing Tranexamic acid (TXA) and Saline in people with Fracture Humerus, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Fracture Humerus
What is being tested?
Tranexamic acid (TXA) and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
12 Apr 2023to 25 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females age 18-100 years
  • Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation.
  • Must be able to read and understand English and consent for themselves.

Who cannot join

  • Allergy to TXA.
  • Acquired disturbances of color vision.
  • History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA.
  • Pregnant or breastfeeding.
  • Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement.
  • Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men)
Show all 9Show fewer
  • Refusal of blood products
  • Subarachnoid hemorrhage
  • Disseminated intravascular coagulation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Allegheny Health Network Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Read the detailed description

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

Being tested
Tranexamic acid (TXA), Saline
Keywords
Open Reduction Internal Fixation, Blood loss
Medical subject headings
Humeral Fractures, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acid (TXA)Drug

    Also called Tranexamic acid

    1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery

  • SalineOther

    control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.

Study groups in NCT05802238
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery
Receives: Drug: Tranexamic acid (TXA)
Control GroupPlacebo comparatorThe control group will have saline administered 10 minutes prior to surgery.
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood loss

    The estimated total blood loss measured intraoperatively. This will be done by estimating absorbed drainage by surgical gauze and adding this to total volume in suction canister. Total volume of irrigation used will be subtracted from this total to give an estimate of intraoperative blood loss.

    Measured: Intraoperatively

Secondary outcomes (3)

  1. Operative Time

    Amount of time of operative procedure

    Measured: From the start of surgical procedure through the completion of the surgical procedure

  2. Duration of follow-up

    Through study completion, an average of one year.

    Measured: Through study completion, an average of one year.

  3. Complications (DVT, PE, stroke)

    Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value.

    Measured: through study completion, an average of one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start12 Apr 2023
  3. Primary completion25 Nov 2024
  4. Study completion25 Nov 2024

Why it stopped: Lack of staffing

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05802238
Sponsor's protocol ID
2021-153
Acronym
TXA
Status last verified
Jun 2024
First submitted
8 Feb 2023
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sun CX, Zhang L, Mi LD, Du GY, Sun XG, He SW. Efficiency and safety of tranexamic acid in reducing blood loss in total shoulder arthroplasty: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jun;96(22):e7015. doi: 10.1097/MD.0000000000007015.

    PubMed 28562553

  • Akgul T, Buget M, Salduz A, Edipoglu IS, Ekinci M, Kucukay S, Sen C. Efficacy of preoperative administration of single high dose intravenous tranexamic acid in reducing blood loss in total knee arthroplasty: A prospective clinical study. Acta Orthop Traumatol Turc. 2016 Aug;50(4):429-31. doi: 10.1016/j.aott.2016.06.007. Epub 2016 Jul 16.

    PubMed 27435332

  • Cheriyan T, Maier SP 2nd, Bianco K, Slobodyanyuk K, Rattenni RN, Lafage V, Schwab FJ, Lonner BS, Errico TJ. Efficacy of tranexamic acid on surgical bleeding in spine surgery: a meta-analysis. Spine J. 2015 Apr 1;15(4):752-61. doi: 10.1016/j.spinee.2015.01.013. Epub 2015 Jan 21.

    PubMed 25617507

  • Yu X, Wang J, Wang X, Xie L, Chen C, Zheng W. The efficacy and safety of tranexamic acid in the treatment of intertrochanteric fracture: an updated meta-analysis of 11 randomized controlled trials. J Thromb Thrombolysis. 2020 Aug;50(2):243-257. doi: 10.1007/s11239-019-02034-1.

    PubMed 31902124

  • Spitler CA, Row ER, Gardner WE 2nd, Swafford RE, Hankins MJ, Nowotarski PJ, Kiner DW. Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial. J Orthop Trauma. 2019 Aug;33(8):371-376. doi: 10.1097/BOT.0000000000001480.

    PubMed 30939507

  • Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.

    PubMed 28983887

  • Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.

    PubMed 28938281

  • Franchini M, Mengoli C, Marietta M, Marano G, Vaglio S, Pupella S, Mannucci PM, Liumbruno GM. Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials. Blood Transfus. 2018 Jan;16(1):36-43. doi: 10.2450//2017.0219-17.

    PubMed 29337665

  • Hooda B, Chouhan RS, Rath GP, Bithal PK, Suri A, Lamsal R. Effect of tranexamic acid on intraoperative blood loss and transfusion requirements in patients undergoing excision of intracranial meningioma. J Clin Neurosci. 2017 Jul;41:132-138. doi: 10.1016/j.jocn.2017.02.053. Epub 2017 Mar 7.

    PubMed 28283245

  • Franchini M, Mengoli C, Cruciani M, Bergamini V, Presti F, Marano G, Pupella S, Vaglio S, Masiello F, Veropalumbo E, Piccinini V, Pati I, Liumbruno GM. Safety and efficacy of tranexamic acid for prevention of obstetric haemorrhage: an updated systematic review and meta-analysis. Blood Transfus. 2018 Jul;16(4):329-337. doi: 10.2450/2018.0026-18. Epub 2018 Apr 3.

    PubMed 29757132

  • Ali Algadiem E, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood Loss Estimation Using Gauze Visual Analogue. Trauma Mon. 2016 May 3;21(2):e34131. doi: 10.5812/traumamon.34131. eCollection 2016 May.

    PubMed 27626017

  • Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.

    PubMed 30516625

  • Cuff DJ, Simon P, Gorman RA 2nd. Randomized prospective evaluation of the use of tranexamic acid and effects on blood loss for proximal humeral fracture surgery. J Shoulder Elbow Surg. 2020 Aug;29(8):1627-1632. doi: 10.1016/j.jse.2020.04.016. Epub 2020 Jun 9.

    PubMed 32713466

  • Yang YY, Qin H, Zheng X, Hu B, Zhang M, Ma T. Administration of Tranexamic Acid in Proximal Humeral Fractures. Indian J Orthop. 2020 May 11;54(Suppl 2):277-282. doi: 10.1007/s43465-020-00128-0. eCollection 2020 Dec.

    PubMed 33194102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tranexamic acid (TXA) and Saline in people with Fracture Humerus, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood loss (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05802238, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.

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